Intended Use
The myoglobin and creatine kinase MB parts are the main markers for the early diagnosis of myocardial infarction (AMI), but may be non-specific for clinical diagnostic purposes. The troponin is the specificity marker; the level of cTnI in blood is abnormal during 4 h after the onset of chest pain was moderate and will peak in 8-16 h. The rising level could be tested within 6-10days. Myo,CK-MB, cTnI mass concentration are sensitive markers for the diagnosis of acute AMI.
The rapid test kit is fast and sensitive for an in vitro qualitative detection of Myo, CK-MB and cTnI in human whole blood, which is for the early and differential diagnosis of myocardial infarction in emergency, intensive care unit, cardiac medicine, health posts and other institutions acute, provides an objective, comprehensive, efficient new means clinical diagnosis of myocardial infarction.
PRINCIPLE
The test is based on the principle of double antibody sandwich immunoassay for the qualitative detection of Myo,CK-MB, cTnI in human serum. Three cards were Myo, CK-MB and cTnI test strip. Each test strip has the control line C (Control) and the test line (Test), the control line coated with anti-mouse antibody and the test line was coated with anti-Myo, CK-MB and cTnI monoclonal antibodies. When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold Myo/CK-MB/cTnI conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with Myo/CK-MB/cTnI antibody that is coated on the test region. If Myo/CK-MB/cTnI is present, the result is the formation of a colored band in the test region. If there is no Myo/CK-MB/cTnI in the sample the area will remain colorless.
The detection thresholds were: Myo: 80ng/ml; CK-MB: 5ng/ml; cTnI: 1ng/ml.
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